Ireland
--:--IST
Recruiting Phase 3

AntiThrombotic Therapy to Ameliorate Clinical Complications in Community Acquired Pneumonia

NCT05848713 · tracked via the Priya Life Science Canada tracker
Phase
Phase 3
Started
2023-10-10
Last updated
2026-09-30

Condition(s) studied

Community-acquired Pneumonia

Investigational drug(s) / intervention(s)

Heparin →

Heparin: Preference is for LMWH given ease of administration and possibility of a more favorable safety profile, if no contraindication is present. Enoxaparin, dalteparin, or tinzaparin are acceptable LMWHs to be used for patients in the investigational arm and dose should be based on measured or estimated weight of the patient. Alternatively, intravenous UFH may be used and may be preferred in the presence of significant renal compromise. Intravenous UFH is typically dosed according to total body weight and pragmatically adjusted according to local institutional policy to achieve an activated partial thromboplastin time (aPTT) of 1.5-2.5x the reference value, or a corresponding UFH anti-Xa level. If UFH is used, the availability of a local site policy that specifies an aPTT target in this range or a corresponding anti-Xa value is a requirement.

Study summary

This is an international, open-label, stratified randomized controlled trial with Bayesian adaptive stopping rules to compare the effects of therapeutic-dose heparin vs. usual care pharmacological thromboprophylaxis on outcomes in patients admitted to hospital with community acquired pneumonia (CAP).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Patients ≥18 years of age 2. Admitted to hospital for a suspected or confirmed diagnosis of CAP defined by: 1. Radiographic evidence of new or worsening infiltrate 2. One or more of the following signs and/or symptoms of lower respiratory tract infection i. New or increased cough or sputum production ii. Fever of \> 37.8C or temperature \< 36C iii. WBC \> 11 x 109/L or \< 4 x 109/L c. The primary diagnosis is believed to be CAP as per the attending physician 3. Requires supplemental oxygen to treat hypoxemia (or requires an increased level of supplemental oxygen if on chronic oxygen therapy) 4. Hospital admission anticipated to last ≥72 hours from randomization Exclusion Criteria: 1. Suspected or confirmed active COVID-19 infection 2. Hospital admission for \>72 hours prior to randomization 3. Patients receiving non-invasive or invasive ventilation, vasopressors, or extracorporeal life support (ECLS) within an ICU at the time of enrollment 4. Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization 5. Patients for whom the intent is to not use pharmacologic thromboprophylaxis 6. Patients with an independent indication for therapeutic-dose anticoagulation 7. Patients with a contraindication to therapeutic-dose anticoagulation, including: 1. Non-traumatic bleeding that requires medical evaluation or hospitalization within 30 days prior to CAP hospital admission 2. History of an inherited or acquired bleeding disorder 3. Cerebral aneurysm or mass lesions of the central nervous system 4. Ischemic stroke within 3 months of hospital admission 5. Gastrointestinal bleeding within 3 months of hospital admission 6. Platelet count \<50 x109/L OR INR \>2.0 OR hemoglobin \<80 g/L at the time of screening 7. Other physician-perceived contraindications to therapeutic anticoagulation 8. History of heparin induced thrombocytopenia (HIT) or other heparin allergy 9. Current or recent (within 7 days of screening) use of dual anti-platelet inhibitors (For example; Aspirin + one of the following; clopidogrel, ticagrelor, prasugrel) 10. Patients in whom imminent death is anticipated 11. Anticipated transfer to another hospital that is not a study site within 72 hours of randomization 12. Enrollment in other interventional trials related to anticoagulation or antiplatelet therapy during current hospitalization

Primary outcome measure(s)

  • Ordinal endpoint reflecting survival — 30 days
    Survival to hospital discharge without ICU-level organ support. Organ support is defined as receipt of high flow nasal oxygen, invasive or non-invasive mechanical ventilation, vasopressor/inotropic therapy, or extracorporeal life support (ECLS) within an ICU. This outcome reflects disease progression to ICU-level organ failure or the worst possible outcome (death). It was chosen because of its importance to patients, clinicians, and other stakeholders. Given the limited number of ICU beds, reducing the burden of critical illness has important health system capacity implications.

Trial sites (68)

FacilityCityRegionStatus
University of Chicago Chicago Illinois Recruiting
Ochsner Clinic Jefferson Louisiana Recruiting
Maine Medical Centre Portland Maine Recruiting
Henry Ford Health System Dearborn Michigan Completed
Cooper University Health Care Camden New Jersey Recruiting
Medical College of Wisconsin Milwaukee Wisconsin Recruiting
Hospital Estadual Dr. Jayme Santos Neves Serra Espírito Santo Recruiting
Hospital Evangelico de Vila Velha Vila Velha Espírito Santo Recruiting
Santa Casa de Misericordia de Itabuna Itabuna Estado de Bahia Completed
Hospital Brasilia Brasília Federal District Completed
Instituto de Cardiologia e Transplantes do Distrito Federal Brasília Federal District Completed
Hospital de Messejana Dr. Carlos Alberto Studart Gomes Goiânia Goiás Recruiting
Hospital Ruy Azeredo Goiânia Goiás Recruiting
Instituto Goiano de Oncologia e Hematologia - INGOH Goiânia Goiás Recruiting
Hospital São Julião Campo Grande Mato Grosso do Sul Recruiting
Santa Casa de Campo Grande Campo Grande Mato Grosso do Sul Recruiting
Hospital Felicio Rocho Belo Horizonte Minas Gerais Completed
NUPEC-Orizonti Belo Horizonte Minas Gerais Completed
Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte Minas Gerais Recruiting
Hospital das Clínicas da Universidade Federal do Triângulo Mineiro Uberaba Minas Gerais Recruiting
Hospital do Rocio Campo Largo Paraná Recruiting
Hospital Santa Cruz Curitiba Paraná Recruiting
PUCPR Curitiba Paraná Completed
Hospital Clementino Fraga Filho - UFRJ Rio de Janeiro Rio de Janeiro Recruiting
Hospital Bruno Born Lajeado Rio Grande do Sul Recruiting
Hospital Sao Vicente de Paulo Passo Fundo Rio Grande do Sul Recruiting
Hospital de Clínicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Hospital Universitario de Santa Maria Santa Maria Rio Grande do Sul Completed
Hospital Sao Jose Criciúma Santa Catarina Recruiting
Hospital Regional Homero Miranda Gomes São José South Carolina Completed
UPECLIN - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu Botucatu São Paulo Recruiting
Hospital Universitario Sao Francisco na Providencia na Deus Bragança Paulista São Paulo Recruiting
Fundação Centro Médico de Campinas Campinas São Paulo Recruiting
IPECC Campinas São Paulo Recruiting
CiTen - Centro Hospital Municipal Antonio Giglio Osasco São Paulo Recruiting
Hospital Regional de Presidente Prudente Presidente Prudente São Paulo Recruiting
Hospital Estadual de Serrana Ribeirão Preto São Paulo Not Yet Recruiting
Hospital Nipo-Brasileiro São Paulo São Paulo Recruiting
HCFMUSP São Paulo São Paulo Recruiting
Santa Casa de Misericordia de Sao Paulo São Paulo São Paulo Completed

+ 28 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05848713 on ClinicalTrials.gov ↗ ← All trials in Canada